FDA.reportPublic FDA data

QUICK-DRAW PLAIN ADAPTER

Primary DI
20857182006085
Brand
QUICK-DRAW PLAIN ADAPTER
Company
Innovative Medical Technologies, Inc.
Model
15-900
Device description
QUICK-DRAW PLAIN ADAPTER FOR USE WITH INNOVAC
Published
2016-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIOTube, Collection, Capillary Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972969000QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.1997-09-22GIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20857182006085PackageGS15In Commercial Distribution
10857182006088PrimaryGS10
00857182006081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085718200608520857182006085
1085718200608810857182006088
00857182006081008571820060818571820060810857182006081

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood transfer tube IVD, EDTAA non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-560-1820support@innovativemedtech.com

Regulatory Flags#

DUNS number
792740578
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857182006477ULTRAFLO-R3633632025-02-13
10857182006484ULTRAFLO-R3643642025-02-13
10857182006491ULTRAFLO-R3653652025-02-13
10857182006507ULTRAFLO-R6876872025-02-13
10857182006576ULTRAFLO-R3233232025-02-13
10857182006583ULTRAFLO-R3243242025-02-13
10857182006590ULTRAFLO-R3263262025-02-13
40857182006508ULTRAFLO-R6886882025-02-13
70857182006509ULTRAFLO-R6896892025-02-13
00857182006265ULTRAFLO-R3383382025-02-13
00857182006623ULTRAFLO-R3363362025-02-13
00857182006661ULTRAFLO-R3353352025-02-13
10857182006330UltraFlo-S2852026-03-12
20857182006337ULTRAFLO-S2852025-02-14
00857182006784UltraFlo-C6810052025-12-30
00857182006807UltraFlo-C6820052025-12-30
10857182006002INNOSET5961212016-06-06
10857182006026INNOSET5961252016-06-06
10857182006088QUICK-DRAW PLAIN ADAPTER15-9002016-08-05
10857182006170ULTRAFLO-S2832025-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059420515SAFECAPDRUMMOND SCIENTIFIC COMPANYGIO2026-05-18
00850059420492MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00850059420508MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00857182006784UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00857182006807UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00848530108113DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
10848530108110DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
00381934774015PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
10381934774012PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
06974621793259LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793266LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793273LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793280LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793297LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793256LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793263LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793270LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793287LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793294LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793303LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793310LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793327LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793300LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793317LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793324LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793334LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793341LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793358LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793365LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
00860001024067MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-05-06